🔬 Drive Clinical Breakthroughs: CRA II - Global FSP Partnership (Home-Based, Sydney/Melbourne)
Join ICON plc's exclusive 22-year global FSP partnership as a CRA II and become an integral extension of a world-leading pharmaceutical company's clinical research team. This home-based role in Sydney or Melbourne places you at the forefront of cutting-edge science in cancer, cardio-metabolic, vaccines, and oncology research—areas representing 70% of our partner's innovative portfolio.
As part of the world's largest clinical research organization, you'll work directly alongside pharmaceutical innovators to accelerate treatments that make meaningful differences in patients' lives. If you're an experienced CRA passionate about therapeutic advancement and seeking career growth within a prestigious dedicated partnership, this is your opportunity to build an exceptional career from anywhere in Australia.
🎯 Your Clinical Mission: Key Responsibilities
Site Management Excellence
- Conduct comprehensive site qualification, initiation, monitoring, and close-out visits for groundbreaking clinical trials across Australia
- Ensure strict protocol compliance, data integrity, and unwavering patient safety throughout the trial lifecycle
- Collaborate closely with leading Australian investigators and site staff to facilitate seamless study conduct
- Perform meticulous data review and rapid query resolution to maintain highest-quality clinical data standards
Therapeutic Area Impact
- Contribute to cutting-edge research across cancer, cardio-metabolic diseases, vaccines, and oncology
- Work on therapeutic areas representing 70% of our partner's innovative portfolio
- Support clinical trials leveraging the latest scientific advancements and treatment modalities
- Ensure research quality that meets global pharmaceutical standards
Partnership Collaboration
- Serve as dedicated extension of world-leading pharmaceutical company's clinical operations
- Work within established 22-year partnership framework ensuring seamless integration
- Contribute to the partner's mission of making positive impacts through innovative science
- Maintain alignment with partner's standards, processes, and quality expectations
Documentation & Compliance
- Contribute to preparation and review of critical study documentation including protocols and clinical study reports
- Ensure all activities comply with Australian regulatory requirements and ICH-GCP guidelines
- Support regulatory submissions and maintain audit-ready documentation
- Apply pharmaceutical partner's specific standards and procedures
⭐ Your Profile: Australian CRA Expertise
Essential Qualifications
- Bachelor's degree in Scientific or Healthcare-related field
- Minimum 2 years experience as Clinical Research Associate within Australia
- Comprehensive understanding of Australian clinical trial regulations and ethics requirements
- Current knowledge of ICH-GCP guidelines and TGA regulatory framework
Technical Competencies
- Experience across all site visit types: qualification, initiation, monitoring, and close-out
- Strong skills in source data verification and case report form review
- Familiarity with electronic data capture systems and clinical trial management platforms
- Understanding of Australian healthcare system and research site landscape
Professional Attributes
- Strong organizational skills with exceptional attention to detail
- Excellent communication abilities for effective collaboration with investigators and site staff
- Independent work ethic with ability to thrive in fast-paced environment
- Problem-solving mindset for addressing complex site challenges
Travel Requirements
- Ability to travel minimum 60% across Australia (domestic and potentially international)
- Valid driver's license for comprehensive site coverage throughout Australia
- Flexibility for extensive travel to research institutions nationwide
- Comfort with fly-and-drive assignments across Australian states and territories
💫 Why Join Our Global FSP Partnership?
Exclusive Pharmaceutical Partnership
- Work as dedicated extension of world-leading pharmaceutical company
- Access to cutting-edge research and innovative therapeutic approaches
- Benefit from 22-year established partnership framework and processes
- Gain experience with pharmaceutical industry standards and expectations
Home-Based Flexibility with Impact
- 100% remote work from Sydney or Melbourne with comprehensive technology support
- Strategic travel to Australia's leading research institutions and hospitals
- Balance autonomous field work with virtual team collaboration
- Professional home office setup with ongoing IT and operational support
Therapeutic Area Advancement
- Focus on high-impact therapeutic areas: cancer, cardio-metabolic, vaccines, oncology
- Contribute to research representing 70% of partner's innovative portfolio
- Work on treatments that address significant unmet medical needs
- Gain specialized experience in growing therapeutic areas
Career Growth within Partnership
- Clear pathway to Senior CRA and Clinical Team Lead positions within FSP model
- Opportunities for therapeutic area specialization and advanced training
- Exposure to global clinical operations and pharmaceutical R&D processes
- Professional development within prestigious dedicated partnership
Competitive ICON Australia Benefits
- Attractive salary package with performance incentives
- Comprehensive private health insurance for you and your family
- Global Employee Assistance Programme with local support
- Generous annual leave with Australian public holidays
- Competitive superannuation contributions and retirement planning
- Travel allowance and expense coverage for site monitoring
- Professional development allowance and certification support
✨ Ready to Advance Clinical Research in Australia?
If you're an experienced CRA with Australian clinical research expertise and passion for therapeutic innovation, we encourage you to apply. This CRA II role within our global FSP partnership offers the unique opportunity to advance your career while contributing to groundbreaking research that transforms patient care worldwide.
Apply Now and become our next Clinical Research expert in Australia!
